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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K262792
Device Name Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
Applicant
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Applicant Contact Christine Stahley
Correspondent
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Correspondent Contact Christine Stahley
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/06/2026
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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